Psychedelic-assisted Therapy Is More Analogous to Oncology Care Than Traditional Mental Health Care

Pharmacy Times® interviewed Manish Agrawal, MD, faculty at the Center for Psychedelic Therapy and Research, co-director of Clinical Research at Aquilino Cancer Center, and co-founder and CEO of Sunstone Therapies, on his research investigating psychedelic-assisted therapies for patients with cancer and his recently published study in JAMA Oncology on psilocybin therapy for patients with cancer and major depression disorder.

Pharmacy Times: As an oncologist, how did you become interested in pursuing a certificate in psychedelic-assisted therapies and research?

Manish Agrawal, MD: Yeah, as I learned about psychedelic-assisted therapy as a possibility that might help my patients, as an oncologist, deal with emotional distress, I was really intrigued that these medicines might be helpful and realized that in my medical and training at the NIH and my research, I didn't know enough about it. So I felt like I needed to really get certification to understand that, and that's how I ended up pursuing this certification to bring myself up to speed about psychedelic medicine research and where the field was.

Pharmacy Times: Mental health challenges during cancer care are often considered outside the scope of oncology professionals. What is your perspective on this?

Agrawal: Yeah, I think I think it's probably evolved over time, and I've been an oncologist for 20 years, and after practicing for 18-19 years, what became very clear is I was very good at helping patients get cancer treatment and treat their cancer and many times be cured, but really not doing a good job affecting the quality of their life, which was determined by their emotional health, and I really didn't have enough tools for it.

When I thought about it, the reason I went into medicine and even oncology was to help the whole person so they would have a longer life, but also a good quality of life. So to me, I think they really go hand in hand.

I show an iceberg when I give a talk, and above the iceberg, I have chemotherapy, radiation, and surgery, and underneath the iceberg, I put psychospiritual care. I think the emotional aspect is part of cancer care. I think you have to take care of the whole iceberg, not just what's above the water, and total cancer care involves treating the whole person, and not just the physical symptoms, and that's what we go to our patients and that's what they want. They want to feel better not just have the cancer treated.

Pharmacy Times: What brought you to your work investigating psilocybin-assisted therapies to address psychological and existential distress in patients with cancer and their families?

Agrawal: Yeah, so I mean, sort of ticking back on my previous thoughts about where this fits in care, after a career in oncology, realizing that there's this huge aspect of the care that's unaddressed. I learned about the research going on it that had happened at Hopkins, as well as NYU and UCLA.

Then I went up and met with Roland Griffiths, PhD, at Johns Hopkins along with Mary Cosimano, LMSW. They showed me their data and shared their stories as well as what they've seen, and that really piqued my interest based on the research that had been done previously, as well as with Stanislav Grof, MD, previously, and the met with William A. Richards, PhD, and all of that really drew me to psilocybin-assisted therapy, given the data that was already present for treatment of cancer patients with psilocybin.

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Pharmacy Times: Health care can be slow to adapt to social and cultural changes occurring in US society. Does this look to be the case for psychedelic medicine and its role in cancer care?

Agrawal: I'm not sure—the story isn't done yet. I would say that since I've been looking at it, and studying it sort of launching our trial couple of years ago, and now its publication today, there's more and more interest in the oncology space.

I wrote an editorial with my partner Paul Thambi, MD, for ASCO, we've presenting abstracts, and so I wouldn't say there's an open embracement of it. At the same time, I think there is an openness because you don't have to talk to an oncologist, there's not one that would deny the emotional distress or existential distress that patients face, and it's being convinced that these therapies actually work and are accessible. So yeah, it's going to feel slow. But I don't see a hard resistance to it right now.

I will say at the same time, it can't be fast enough, because there's many patients that need it now. Some of them—many of them—will pass away before they have access to it, and now that it's there for everyone, but it should be accessible for those that need it.

Pharmacy Times: What is the role of psychedelic medicine in cancer care in your view, and where are we in introducing psychedelic medicine in oncology and vice versa?

Agrawal: Yeah, I think that there's been several small trials, including ours, that have shown or suggested a potential benefit with psychedelic-assisted therapy in cancer associated depression or distress. So, there's some data there, but there's not a large randomized study looking at this versus placebo.

I think, in some ways, the field is a bit stuck there because the FDA is asking: Is depression in oncology different than depression in general, and should there be a separate trial for that or not? Or if it gets rescheduled as a treatment for depression for the general population, can cancer patients just fit under that? So there are ongoing studies looking at cancer patients and the use of psychedelics. Currently, there are no large, randomized studies that are looking at answering this question.

Pharmacy Times: Could you discuss the research you recently published in JAMA Oncology on psilocybin therapy for patients with cancer and major depression disorder?

Agrawal: Yeah, so I mean, the study that we just published was novel in that it used a group approach, as well as was done in a community cancer center. So all the previous studies using psychedelic-assisted therapy in cancer patients were done in specialized academic hospitals or in large psychiatric [facilities]. Our study was done in a community cancer center, and so on the first floor of our building is a radiation facility, and on the second floor is where the chemotherapy and the medical oncologists live, and third floor, there's a PET scanner, and we have the Bill Richards Center for Healing, where patients come in and can get psychedelic-assisted therapy beyond clinical trials. So that's a novel approach, and that patients in the community are coming rather than going to a specialized place.

But even more novel is our group approach, which is that we treated in groups of 3 to 4 patients at a time, where they would come in and have a group preparation, and then all 4 get psilocybin at the same time in 4 rooms that were adjacent to each other—so we call that simultaneous administration. And then the next day, [they] come back and talk about their experience, and then again a week later [they] talk about their experience—[that’s] called integration. So that has not yet been done in cancer patients, or really any population, where there was a simultaneous administration, group prep, and group integration all at the same time. So we were really excited about that.

We [also] had 1 to 1 therapists instead of 2 to 1 therapists with 1 lead. And so that is less resource intensive, and potentially makes it more scalable. But even more exciting was people really found a connection in the group and found a benefit in speaking about their experience and their story together. And even though the trials completed, and people followed up for 8 weeks, people continued to meet once a month now 2 years later, because of the benefits they found.

The trials showed quite remarkable results. Eighty percent of the participants had more than 50% reduction in their depression symptoms based on the MADRS and 50% had a complete remission, that is their MADRS score came down to the same level as someone that did not have depression. So it's quite a small study at 30 patients, so it has limitations for sure, there was no placebo arm, but still the efficacy was quite interesting and profound.

Pharmacy Times: What are some challenges you see ahead as oncology professionals look to consider psychedelic medicine for patients?

Agrawal: Well, it's a complex delivery, it's actually much more analogous to oncology care than it is to traditional mental health. So as an oncologist, you see a patient and then you look over the records and assess whether they're appropriate for chemotherapy or treatment. And then if they are, you prepare them for treatment and go over the side effects, what to expect, then they come in and they get the chemotherapy with a nurse monitoring the whole time, and then they come back for toxicity assessment. So it's multidisciplinary care with nurses and other coordinators.

Similarly, psychedelic care requires a screening, preparation, then the dosing and integration. So I think in many ways, oncologists will be more familiar with this type of delivery than even mental health practitioners because that is how cancer care is delivered. That being said, they'll also appreciate the complexity of the delivery—that you'll need a team of people that are trained, that know how to administer the medicine, how to be safe, how to support the person, and how to manage anything that comes up. So they'll be familiar, and yet familiarity will help them understand how complex the delivery is, and it just can't be done overnight. You have to have training and facilities and the right personnel for it.

Pharmacy Times: What is the role of the pharmacist in patient care related to psychedelic medicine in cancer care?

Agrawal: Pharmacists’ role would be the same as in like chemotherapy and other oral medications that are given for are cancer. They're highly specialized, they'll be expensive, and they'll have to be handled with some safety and installed properly. So far, they're not yet intravenous. Most of them are oral, but the pharmacists will have to store and manage medications like they do other oral pharmaceuticals for oncology patients.

The other piece, actually, that will be familiar to pharmacists will be the REMS program, and so there's a safety component to that that they'll have to be familiar with, and then the medication won't be just be able to be given by just anyone and they'll have to be special licenses. And so in that way, the pharmacists will be involved in the storage, correct administration, as well as the REMS program and making sure that the correct licensed professional is able to administer the medication.